Surgery, Mechanical Ventilation Complication, Pulmonary Complication
Conditions
Keywords
Surgery, Mechanical ventilation, PEEP, Postoperative pulmonary complications, Individual patient data meta-analysis
Brief summary
Aiming to understand the isolated impact of high PEEP in patients undergoing mechanical ventilation for general anesthesia for surgery, three appropriately sized international multicentre randomized controlled trials have been performed over recent years: the 'PROtective Ventilation using HIgh versus LOw PEEP trial (PROVHILO), the 'individualized PeRioperative Open-lung Ventilation trial' (iPROVE), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE). These three trials had several similarities in key areas of their study protocols, inclusion and exclusion criteria, and collected data, and even the primary and secondary outcomes. Of note, the three trials combined high PEEP with recruitment manoeuvres. This allows an individual patient data meta-analysis.
Interventions
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Carl Gustav Carus
Hospital Clínico Universitario de Valencia
Hospital Israelita Albert Einstein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Enrolled into one of the three studies (PROVHILO, iPROVE or PROBESE) to either high PEEP or low PEEP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative pulmonary complications | Until day seven or hospital discharge, whichever comes first | Collapsed composite of complications developing within the first seven postoperative days, including: Mild respiratory failure; or Severe respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or Pulmonary infection; or Pleural effusion; or Atelectasis; or Pneumothorax; or Bronchospasm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of extrapulmonary pulmonary complications | Until day seven or hospital discharge, whichever comes first | Collapsed composite of complications developing within the first seven postoperative days, including: Systemic Response Inflammatory Syndrome; or Sepsis; or Septic Shock; or Acute Kidney Injury. |
| Incidence of intraoperative complications | Intraoperatively | Defined as intraoperative hypotension; or need for rescue for desaturations; or need for vasoactive drugs. |
| Incidence of intensive care unit admission | Until hospital discharge, death or 100 days, whichever comes first | Incidence of intensive care unit admission during hospital stay |
| Incidence of severe postoperative pulmonary complications | Until day seven or hospital discharge, whichever comes first | Collapsed composite of complications developing within the first seven postoperative days, including: Severe respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or Pulmonary infection; or Pleural effusion; or Atelectasis; or Pneumothorax; or Bronchospasm |
| Incidence of 7-day mortality | Until day seven or hospital discharge, whichever comes first | Mortality during the first seven days of hospitalization |
| Incidence of in-hospital mortality | Until hospital discharge, death or 100 days, whichever comes first | Mortality during hospitalization |
| Incidence of major postoperative complications | Until day seven or hospital discharge, whichever comes first | Collapsed composite of complications developing within the first seven postoperative combining severe postoperative pulmonary complications, sepsis, septic shock and/or acute kidney injury) |
| Hospital length of stay | Until hospital discharge, death or 100 days, whichever comes first | Duration of hospital length of stay in days |
Countries
Germany, Netherlands, Spain
Outcome results
None listed